Bristol-Myers Squibb Company (NYSE: BMY) announced today that 20 abstracts have been accepted for presentation at the 2013 annual meeting of the American College of Rheumatology (ACR) taking place from October 25-30 in San Diego, CA. The breadth of data underscores the Company’s continued commitment to develop medicines that address the unmet medical needs of patients suffering from rheumatic and other immune-mediated diseases. Key presentations include:
- The first presentation of efficacy and safety results from a Phase IIb study of subcutaneous (SC) clazakizumab, an investigational anti-IL-6 monoclonal antibody, in adults with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate. Bristol-Myers Squibb has exclusive worldwide rights to develop and commercialize clazakizumab for all indications outside of cancer under a collaboration agreement with its discoverer, Alder Biopharmaceuticals.
- Results from the two-year AMPLE trial of Orencia® SC (abatacept) and Humira® (adalimumab) in biologic-naive RA patients, including efficacy, safety and patient-reported outcomes data.
- More than 10 health economics and outcomes research presentations that add to the collective understanding of real-world use of RA medications and the costs associated with treatment.
|A Phase IIb Study Of The Efficacy and Safety Of Subcutaneous Clazakizumab (anti-IL-6 monoclonal antibody) With Or Without Methotrexate In Adults With Moderate-To-Severe Active Rheumatoid Arthritis and An Inadequate Response To Methotrexate||Oral Presentation October 28 2:30 - 4 pm|
|Anti-IL-6 Antibody Clazakizumab Is More Potent Than Tocilizumab In Blocking In Vitro and Ex Vivo IL-6-Induced Functions||October 29|
|Head-To-Head Comparison of Subcutaneous Abatacept Versus Adalimumab on Background Methotrexate in RA: Two Year Results from the AMPLE Study||October 29|
|2-Year Results from the AMPLE (Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Patients with Background Methotrexate) Trial: Changes in Patient-Reported Outcomes in Response to Subcutaneous Abatacept or Adalimumab in Rheumatoid Arthritis||October 27|
|Effects of SC Abatacept or Adalimumab on Remission and Associated Changes in Physical Function and Radiographic Outcomes: Two Year Results from the AMPLE Trial||October 27|
|Abatacept or anti-TNF monoclonal antibodies: Efficacy and safety comparisons||October 29|
|Antibody response to pneumococcal and influenza vaccination in patients with RA receiving subcutaneous abatacept||October 27|
|Adherence to the Recommended Dosing Regimen of Abatacept in the Real-world Setting in the ACTION Study: Is There a Dose-creep in Overweight Patients?||October 28|
|Gene expression in whole blood predicts the abatacept-methotrexate combination responsiveness in rheumatoid arthritis: preliminary results||October 29|
|Abatacept is highly effective at inhibiting T cell priming and induces a unique transcriptional profile in CD4+ T cells||October 27|
|Pilot Study of Abatacept in Patients with Refractory Autoimmune Chronic Urticaria||October 29|
|Musculoskeletal Hospital Admissions Among Patients Treated For Rheumatoid Arthritis Between 1999 and 2010 Compared With The General Population In The Netherlands||October 27|
|Evaluation Of Hospitalizations and Costs In Patients With Rheumatoid Arthritis In United States Medicare Population||October 28|
|Analysis Of Non-Steroidal Anti-Inflammatory Drug Burden Among Rheumatoid Arthritis Patients Using The Dougados Algorithm||October 27|
|Biologic Switching Rates among Patients with Rheumatoid Arthritis in Medicare||October 29|
|Rates of Switching and Healthcare Costs Associated with Switching Biologic Disease-modifying Antirheumatic Drugs in a Commercial Population: Evidence from Real-world Observational Studies||October 28|
|Outcomes of patients with rheumatoid arthritis and comorbid hyperlipidaemia||October 27|
|Prevalence of Systemic Lupus Erythematosus and Lupus Nephritis in the United States: Analysis of Commercial and Public Insurance Billing Data||October 28|
|Coronary endothelial dysfunction directly measured by N13 Positron Emission Tomography (PET) is detected in established Rheumatoid Arthritis (RA), but not early RA||October 27|
|Assessing Validity Of Low Field Magnetic Resonance Imaging (MRI) for Joint Inflammation and Damage In Wrist/Hand Rheumatoid Arthritis (RA) - A Systematic Literature Review (SLR)||October 29|
Infections: If you have any kind of infection, even if it is small (such as an open cut or sore), an infection that is in your whole body (such as the flu), an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you get any of the symptoms of TB (a dry cough that does not go away, weight loss, fever, night sweats), call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test. If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis. If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD). If you are scheduled to have Surgery. Allergies to the Ingredients of ORENCIA ® (abatacept): The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration. The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection. Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for 3 months after you stop receiving ORENCIA, you should not take live vaccines. Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. ORENCIA for SC injection does not contain maltose; therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously. Pregnancy: If you are pregnant, planning to become pregnant, or are thinking about becoming pregnant. It is not known if ORENCIA can harm your unborn baby. Breastfeeding: You will need to decide to either breast-feed or receive treatment with ORENCIA, but not both. If you Take Any Other Kinds of Medicine, including prescription and nonprescription medicines, vitamins, and herbal supplements. If you are Taking Other Biologic Medicines to Treat RA such as: Enbrel ® (etanercept), Humira ® (adalimumab), Remicade ® (infliximab), Kineret ® (anakinra), Rituxan ® (rituximab), Simponi ® (golimumab), Cimzia ® (certolizumab pegol), Actemra ® (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines. Possible Side Effects of ORENCIA ® (abatacept) ORENCIA can cause serious side effects including:
- Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red or painful skin.
- Allergic reactions. Allergic reactions can happen on the day of treatment or the day after receiving ORENCIA. Tell your healthcare provider or get emergency medical help right away if you have hives; swollen face, eyelids, lips, or tongue; or trouble breathing.
- Hepatitis B infection. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start or while using ORENCIA.
- Vaccinations. You should not receive ORENCIA® (abatacept) with certain types of vaccines. ORENCIA may cause some vaccinations to be less effective.
- Respiratory problems in patients with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, pneumonia, cough, or trouble breathing.
- Cancer (malignancies). Certain kinds of cancer have been reported in patients receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.